Methylphenidate Shared Care Agreement For attention deficit hyperactivity disorder (ADHD) in adults Effective Shared Care Agreement Section 1: Shared Care arrangements and responsibilities Section 1.1 Agreement to transfer of prescribing of Methylphenidate Patient details Name: Address: Date of Birth: NHS number: Contact details Specialist: Address: Email: Contact number: GP Address: Email: Contact number: Agreement to shared care, to be signed by GP and Specialist before prescribing is transferred to GP Specialist Signature: Date: GP Signature: Date: Patient Name: Contact number: Patient Signature: Date:
Section 1.2: Areas of responsibility for shared care This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of methylphenidate for treatment of patients with attention deficit hyperactivity disorder (ADHD) can be shared between the specialist and General Practitioner (GP). The prescribing of methylphenidate in adults is off-label use. GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. Sharing of care assumes good communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with ADHD will be under regular specialist follow-up, which provides an opportunity to discuss drug therapy. The prescriber of the medication legally assumes clinical responsibility for the drug and the consequences of its use. Roles & Responsibilities Specialist s responsibilities 1 Confirm diagnosis of ADHD following full assessment. 2 Carry out a pre-drug treatment assessment 1. This must include A full mental health history & social assessment A full history & physical examination, including: o Assessment of history of exercise syncope, undue breathlessness and other cardiovascular symptoms o Heart rate and blood pressure (plot on a centile chart) o Height and weight (plot on a growth chart) o Family history of cardiac disease and examination of the cardiovascular system An electrocardiogram (ECG) if there is past medical or family history of serious cardiac disease, a history of sudden death in young family members or abnormal findings on cardiac examination. Risk assessment for substance misuse or drug diversion. 3 Initiate treatment and titrate dose over 4-6 week period 1. 4 After titration and dose stabilisation write to the patient s GP to request agreement to shared care. 5 Review patient every 3 months or sooner if indicated. 6 Monitor weight measure 3 and 6 months after the start of treatment, and every 6 months thereafter 1 7 Monitor onset or worsening of psychiatric symptoms (such as depression, suicidal thoughts, hostility, anxiety, agitation, psychosis, or mania) and symptoms suggestive of heart disease 2. 8 Monitor heart rate and blood pressure before and after each dose change, and every 3 months 1. 9 Provide GP with regular (every 3-6 months) reports on heart rate, blood pressure, weight 2
and height. 10 Ensure that treatment is interrupted at least yearly to determine whether continuation is needed 2 11 Stop treatment at any appropriate time; communicate change or cessation of treatment to GP. General Practitioner s responsibilities 1 Respond to specialists request regarding shared care as soon as possible ensure that treatment has been initiated, titrated and stabilised before agreeing to shared care 3. NB Do not diagnose or start drug treatment for ADHD in adults in primary care 1. 2 Issue monthly prescriptions as advised by specialist maximum of 30 days recommended 4 (NB. CD requirements) 3 Monitoring the patient s overall health and well-being annually. 4 Report adverse drug reactions to specialist. 5 Act upon results communicated by specialist. 6 Referral back to specialist for early appointment if patient or parents raise concerns. Patient responsibilities 1 To attend appointments 2 To have the recommended tests. 3 To inform the GP if health problems arise. 4 To be aware of drug actions and side effects and report any relevant symptoms. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: Email address: Specialist: Other: 3
Section 2: Supporting information See Summary of Product Characteristics (SPC) Methylphenidate (immediate-release methylphenidate, Equasym, Equasym XL, Concerta XL, Medikinet XL ) for full prescribing information www.emc.medicines.org.uk ADHD is a heterogeneous behavioural syndrome characterised by the core symptoms of inattention, hyperactivity and impulsivity. Not every person with ADHD has all of these symptoms some people are predominantly hyperactive and impulsive; others are mainly inattentive. Symptoms of ADHD are distributed throughout the population and vary in severity; only those people with at least a moderate degree of psychological, social and/or educational or occupational impairment in multiple settings should be diagnosed with ADHD. Determining the severity of ADHD is a matter for clinical judgment, taking into account severity of impairment, pervasiveness, individual factors and familial and social context. Symptoms of ADHD can overlap with those of other disorders, and ADHD cannot be considered a categorical diagnosis. Therefore care in differential diagnosis is needed. ADHD is also persistent and many young people with ADHD will go on to have significant difficulties in adult life. The recommendation for treatment is outlined in NICE Clinical Guideline 72 which states that Drug treatment is the first-line treatment for adults with ADHD with either moderate or severe levels of impairment. Methylphenidate is the first-line drug 1. Drug treatment for adults with ADHD should always form part of a comprehensive treatment programme that addresses psychological, behavioural and educational or occupational needs Diagnosis Diagnosis should only be made by a specialist psychiatrist, paediatrician or other healthcare professional with training and expertise in the diagnosis of ADHD 1. Do not diagnose or start drug treatment for ADHD in adults in primary care. Drug treatment Drug treatment for adults with ADHD should be started only under the guidance of a psychiatrist, nurse prescriber specialising in ADHD, or other clinical prescriber with training in the diagnosis and management of ADHD. As a general principle the NICE guideline states that following titration and dose stabilisation, prescribing and monitoring should be carried out under locally agreed shared care arrangements with primary care The NICE guideline states that a pre-drug treatment assessment should be completed, including: A full mental health and social assessment, A full history and physical examination, including: o Assessment of history of exercise syncope, undue breathlessness and other cardiovascular symptoms, o Heart rate and blood pressure (plot on a centile chart) 4
o Weight o Family history of cardiac disease and examination of the cardiovascular system An electrocardiogram (ECG) if there is past medical or family history of serious cardiac disease, a history of sudden death in young family members or abnormal findings on cardiac examination Risk assessment for substance misuse and drug diversion. Indication At present methylphenidate does not have UK marketing authorisation for the treatment of adults with ADHD, although most products support the use in adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, starting treatment in adults is not appropriate. NICE recommends that prescribers should advise people with ADHD implications of prescribing unlicensed or off-label drugs. Informed consent should be obtained and documented. Presentation and availability Methylphenidate is available in immediate release (methylphenidate hydrochloride) and modified release formulations (Concerta XL, Xenidate XL, Equasym XL and Medikinet XL ). If clinically appropriate, the preferred 1st line formulary choice is Xenidate XL It is a controlled drug and prescriptions must comply with full legal requirements (see BNF) Methylphenidate: immediate- and modified-release equivalents (mg) 1 IR-MPH Concerta XL Equasym XL Medikinet XL Xenidate XL 10-10 10-15 18 - - 18 20-20 20-30 36 30 30 36 - - - 40-45 54 - - 54 60 72* 60 - IR-MPH: immediate-release methylphenidate; * licensed up to 54mg If clinically appropriate, the preferred 1 st line formulary choice is Xenidate XL Monitoring 1 Consider using standard symptoms and side effect rating scales during treatment as an adjunct to clinical assessment. Routine blood tests and ECGs are not recommended unless there is a clinical indication. 5
Measure weight 3 and 6 months after the start of treatment, and every 6 months thereafter (plot on growth chart). Monitor heart rate and blood pressure and record on a centile chart before and after each dose change, and every 3 months. Sustained resting tachycardia, arrhythmia or systolic blood pressure greater than the 95 th percentile (or a clinically significant increase) measure on two occasions should prompt dose reduction and referral. Safety The most common adverse events reported with treatment are decreased appetite, insomnia, headache and stomach ache. 1 Attention deficit hyperactivity disorder. Diagnosis and management of ADHD in children, young people and adults. NICE clinical guideline 72. September 2008 2 MHRA. Drug Safety Update. January 2010 pages 5-6 3 MTRAC Guidelines Methylphenidate for the treatment of attention deficit hyperactivity disorder. VS 02/18 4 A guide to good practice in the management of controlled drugs in primary care (England). National Prescribing Centre (Second Edition). February 2007 6